Impact of IVDR on an Italian Academic Diagnostic Laboratory ESCCA 2021 – The BD Industrial Partner Presentation
May 04, 2022
The European In Vitro Diagnostic Medical Device Regulation (IVDR) (EU) 2017/746 came into effect on 26 May 2017 and will replace the European In Vitro Diagnostic Medical Device Directive 98/79/EC (IVDD) on 26 May 2022. The IVDR aims to ensure that in vitro diagnostic medical devices (IVDs) that are placed, made available, or put into service in the European market meet adequate safety and performance standards. The IVDR also sets out new rules for applying the CE mark to IVDs. Companies who wish to continue placing their devices on the market will have to meet enhanced requirements to support the safety and performance of devices.
One of the key requirements of the IVDR is the Statement of Intended Purpose, which must provide information on all the characteristics of the IVD, and must be included in the labelling. The intended purpose of the device together with the inherent risks serve as the basis for the new risk-based classification of IVDs.
Unlike in the IVDD, Lab-Developed Tests (LDTs), or diagnostic tools which are designed, manufactured and used within a health institution (HI), are now governed by the IVDR. The IVDR allows the use of LDTs only if either all applicable requirements of the entire IVDR are met, or if the HI meets all the conditions as stated in Article 5(5) of the IVDR. In the latter case, the HI can benefit from the exemption, so the LDT only needs to meet the General Safety and Performance Requirements (GSPR). One of the conditions of Article 5(5) is that use of an LDT is allowed only in the absence of a CE -marked alternative or if the performance of the equivalent CE-marked device is not sufficient or the device is not appropriate for the target patient group.
In addition, EU Member States will have the right to restrict the manufacture and use of LDTs and may inspect the activities of the HI.
In this talk, Prof. Alessandra Biffi of the Division of Paediatric Haematology, Oncology and Stem Cell Transplant, University of Padua, Italy, explains how her lab, which has developed LDTs, is preparing itself to meet the requirements of the IVDR. Prof. Biffi talks about the importance of ISO 15189 compliance (or, where applicable, national provisions, including national provisions regarding accreditation), one of the conditions per Article 5(5). She also talks about the classification of IVDs, the importance of personnel training, the review of the lab LDTs assays portfolio and the related documentation, to identify gaps and to ensure that the lab is ready to comply with the applicable IVDR requirements for LDTs.
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The views expressed by the speaker are her personal opinions. The approach taken towards the preparation for IVDR that is discussed in this video are specific, and may not be applicable in all situations. BD and its associates do not recommend or endorse the approach towards IVDR compliance that is discussed in this video.
